Internal indifferent electrode device for use with lesion creation apparatus and method of forming lesions using same

ABSTRACT

An internal indifferent electrode device including a flexible shaft, an energy transmission device adapted to be inserted into the body supported on the shaft, and a connector adapted to mate with the power return connector of a power supply apparatus.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 11/864,567, filed Sep. 28, 2007, now U.S. Pat. No. 8,758,335;which is a continuation of U.S. application Ser. No. 10/980,845, filedNov. 3, 2004, now U.S. Pat. No. 7,288,090; which is a continuation ofU.S. application Ser. No. 09/801,416, filed Mar. 7, 2001, now U.S. Pat.No. 6,827,714, the disclosures of which are hereby incorporated byreference into the present application in its entirety.

BACKGROUND OF THE INVENTIONS

1. Field of the Inventions

The present inventions relate generally to electrophysiological devicesand, more particularly, to the indifferent electrodes that are used inconjunction with electrophysiological devices.

2. Description of the Related Art

There are many instances where diagnostic and therapeutic elements mustbe inserted into the body. One instance involves the treatment ofcardiac conditions such as atrial fibrillation and atrial flutter whichlead to an unpleasant, irregular heartbeat, called arrhythmia.

Normal sinus rhythm of the heart begins with the sinoatrial node (or “SAnode”) generating an electrical impulse. The impulse usually propagatesuniformly across the right and left atria and the atrial septum to theatrioventricular node (or “AV node”). This propagation causes the atriato contract in an organized way to transport blood from the atria to theventricles, and to provide timed stimulation of the ventricles. The AVnode regulates the propagation delay to the atrioventricular bundle (or“HIS” bundle). This coordination of the electrical activity of the heartcauses atrial systole during ventricular diastole. This, in turn,improves the mechanical function of the heart. Atrial fibrillationoccurs when anatomical obstacles in the heart disrupt the normallyuniform propagation of electrical impulses in the atria. Theseanatomical obstacles (called “conduction blocks”) can cause theelectrical impulse to degenerate into several circular wavelets thatcirculate about the obstacles. These wavelets, called “reentrycircuits,” disrupt the normally uniform activation of the left and rightatria.

Because of a loss of atrioventricular synchrony, the people who sufferfrom atrial fibrillation and flutter also suffer the consequences ofimpaired hemodynamics and loss of cardiac efficiency. They are also atgreater risk of stroke and other thromboembolic complications because ofloss of effective contraction and atrial stasis.

Although pharmacological treatment is available for atrial fibrillationand flutter, the treatment is far from perfect. For example, certainantiarrhythmic drugs, like quinidine, amiodarone, and procainamide, canreduce both the incidence and the duration of atrial fibrillationepisodes. Yet, these drugs often fail to maintain sinus rhythm in thepatient. Cardioactive drugs, like digitalis, Beta blockers, and calciumchannel blockers, can also be given to control the ventricular response.However, many people are intolerant to such drugs. Anticoagulant therapyalso combats thromboembolic complications, but does not eliminate them.Unfortunately, pharmacological remedies often do not remedy thesubjective symptoms associated with an irregular heartbeat. They also donot restore cardiac hemodynamics to normal and remove the risk ofthromboembolism.

Many believe that the only way to really treat all three detrimentalresults of atrial fibrillation and flutter is to actively interrupt allof the potential pathways for atrial reentry circuits.

One surgical method of treating atrial fibrillation by interruptingpathways for reentry circuits is the so-called “maze procedure” whichrelies on a prescribed pattern of incisions to anatomically create aconvoluted path, or maze, for electrical propagation within the left andright atria. The incisions direct the electrical impulse from the SAnode along a specified route through all regions of both atria, causinguniform contraction required for normal atrial transport function. Theincisions finally direct the impulse to the AV node to activate theventricles, restoring normal atrioventricular synchrony. The incisionsare also carefully placed to interrupt the conduction routes of the mostcommon reentry circuits. The maze procedure has been found veryeffective in curing atrial fibrillation. However, the maze procedure istechnically difficult to do. It also requires open heart surgery and isvery expensive. Thus, despite its considerable clinical success, only afew maze procedures are done each year.

Maze-like procedures have also been developed utilizing catheters whichcan form lesions on the endocardium to effectively create a maze forelectrical conduction in a predetermined path. Exemplary catheters aredisclosed in commonly assigned U.S. Pat. No. 5,582,609. Typically, thelesions are formed by ablating tissue with one or more electrodescarried by the catheter. Electromagnetic radio frequency (“RF”) energyapplied by the electrodes heats, and eventually kills (i.e. “ablates”),the tissue to form a lesion. During the ablation of soft tissue (i.e.tissue other than blood, bone and connective tissue), tissue coagulationoccurs and it is the coagulation that kills the tissue. Thus, referencesto the ablation of soft tissue are necessarily references to soft tissuecoagulation. “Tissue coagulation” is the process of cross-linkingproteins in tissue to cause the tissue to jell. In soft tissue, it isthe fluid within the tissue cell membranes that jells to kill the cells,thereby killing the tissue.

Catheters used to create lesions (the lesions being 3 to 15 cm inlength) typically include a relatively long and relatively flexible bodyportion that has a plurality electrodes supported or near its distalend. The portion of the catheter body portion that is inserted into thepatient is typically from 23 to 55 inches in length and there may beanother 8 to 15 inches, including a handle, outside the patient. Theproximal end of the catheter body is connected to the handle whichincludes steering controls. The length and flexibility of the catheterbody allow the catheter to be inserted into a main vein or artery(typically the femoral artery), directed into the interior of the heart,and then manipulated such that the electrode contacts the tissue that isto be ablated. Fluoroscopic imaging is used to provide the physicianwith a visual indication of the location of the catheter.

Although catheter-based soft tissue coagulation has proven to be asignificant advance in the medical arts generally and in the treatmentof cardiac conditions in particular, it is not appropriate in everysituation. Physicians may, for example, desire to perform a mazeprocedure as a supplemental procedure during an open heart surgicalprocedure such as a mitral valve replacement. Physicians may also desireto form lesions on the epicardial surface. Surgical probes which includea relatively short shaft that supports a plurality of electrodes havebeen introduced in recent years to facilitate the formation of lesionsin these situations. Exemplary surgical probes are disclosed in commonlyassigned U.S. Pat. No. 6,142,994, which is entitled “Surgical Method AndApparatus For Introducing Diagnostic And Therapeutic Elements Within TheBody,” which is incorporated here by reference.

Soft tissue coagulation that is performed using electrodes to transmitenergy to tissue, whether catheter-based or surgical probe-based, may beperformed in both bi-polar and uni-polar modes. Both modes require oneor more indifferent return electrodes. In the uni-polar mode, energyemitted by the electrodes supported on the catheter or surgical probe isreturned through one or more indifferent patch electrodes that areexternally attached to the skin of the patient. Bi-polar devices, on theother hand, typically include a number of bi-polar electrode pairs. Bothelectrodes in each pair are supported by the catheter or surgical probeand energy emitted by one electrode in a particular pair is returned byway of the other electrode in that pair.

The uni-polar mode has proven to be superior to the bi-polar modebecause the uni-polar mode allows for individual electrode control,while the bi-polar mode only allows electrode pairs to be controlled.Nevertheless, the inventor herein has determined that conventionaluni-polar soft tissue coagulation techniques can be problematic becausesome patients have delicate skin and/or skin infections that precludethe attachment of an indifferent patch electrode to their skin. Poorindifferent electrode/skin contact can also be a problem, as can localburning. The inventor herein has also determined that it would bedesirable to improve the likelihood that soft tissue coagulationprocedures will result in transmural lesions, which is not always thecase when conventional techniques are employed.

SUMMARY OF THE INVENTIONS

Accordingly, the general object of the present inventions is to providemethods and apparatus that avoid, for practical purposes, theaforementioned problems. In particular, one object of the presentinventions is to provide methods and apparatus that can be used tocreate lesions in a more efficient manner than conventional apparatus.Another object of the present inventions is to provide methods andapparatus that facilitates uni-polar soft tissue coagulation without theproblems associated with placing external patch electrodes on thepatient's skin. Still another object of the present inventions is toprovide methods and apparatus that are more likely to produce transmurallesions than conventional methods and apparatus.

In order to accomplish some of these and other objectives, an internalindifferent electrode device in accordance with a present inventionincludes a flexible shaft, an energy transmission device adapted to beinserted into the body supported on the shaft, and a connector adaptedto mate with the power return connector of a power supply apparatus.There are a number of advantages associated with such a device. Forexample, the present internal indifferent electrode device may be placedwithin the patient and, therefore, allows physicians to performuni-polar lesion formation procedures in such a manner that the issuesassociated with delicate skin and/or skin infections are eliminated.

In order to accomplish some of these and other objectives, a method inaccordance with the present invention includes the steps of positioningan internal indifferent electrode device within the body on one side ofa tissue structure wall, positioning an electrophysiological devicewithin the body on the other side of the tissue structure wall, andtransmitting energy from the electrophysiological device to the internalindifferent electrode device.

There are a number of advantages associated with such a method. Forexample, in one exemplary implementation, the internal indifferentelectrode device will be placed in the blood pool within the left atriumand the electrophysiological device will be placed on the epicardialsurface. Such an arrangement improves the lesion formation process andincreases the likelihood of the formation of transmural lesions, ascompared to epicardial processes where an external patch electrode isplaced on the patient's skin, because the resistivity of blood is lowerthan that of other body tissue. The lowest resistivity path from theelectrophysiological device to the indifferent electrode is, therefore,across the atrial wall and through the blood pool in the atrium. Thepresent method also eliminates the indifferent electrode/skin contactproblems associated with conventional methods. The flowing blood withinthe atrium will also cool the indifferent electrode, thereby reducingthe likelihood of local tissue burning that is sometimes associated withexternal patch electrodes.

The above described and many other features and attendant advantages ofthe present inventions will become apparent as the inventions becomebetter understood by reference to the following detailed descriptionwhen considered in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Detailed description of preferred embodiments of the inventions will bemade with reference to the accompanying drawings.

FIG. 1 is a plan view showing an internal indifferent electrode devicein accordance with a preferred embodiment of a present invention.

FIG. 2 section view taken along line 2-2 in FIG. 1.

FIG. 3 is a perspective view of one of the connectors in the internalindifferent electrode device illustrated in FIG. 1.

FIG. 4 is a front elevation view of an electrosurgical unit inaccordance with a preferred embodiment of a present invention.

FIG. 5 is a plan view of an electrophysiological procedure kit includinga surgical probe and an internal indifferent electrode device inaccordance with a preferred embodiment of a present invention.

FIG. 6 is a plan view of the surgical probe illustrated in FIG. 5.

FIG. 7 is a partial section view of the distal portion of the surgicalprobe illustrated in FIGS. 5 and 6.

FIG. 8 is a section view taken along line 8-8 in FIG. 6.

FIG. 9 is a section view taken along line 9-9 in FIG. 7.

FIG. 10 is a section view of an alternative probe distal section.

FIG. 11 is a perspective view of a surgical probe connection device inaccordance with a preferred embodiment of a present invention.

FIG. 12 is a section view of a human heart during a lesion formationprocedure employing the surgical probe and internal indifferentelectrode kit illustrated in FIG. 5.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following is a detailed description of the best presently knownmodes of carrying out the inventions. This description is not to betaken in a limiting sense, but is made merely for the purpose ofillustrating the general principles of the inventions.

The detailed description of the preferred embodiments is organized asfollows:

I. Internal Indifferent Electrode Device

II. Electrophysiological Procedure Kit

III. Electrodes, Temperature Sensing And Power Control

IV. Methods

The section titles and overall organization of the present detaileddescription are for the purpose of convenience only and are not intendedto limit the present inventions.

This specification discloses a number of structures, mainly in thecontext of cardiac ablation, because the structures are well suited foruse with myocardial tissue. Nevertheless, it should be appreciated thatthe structures are applicable for use in therapies involving other typesof soft tissue. For example, various aspects of the present inventionshave applications in procedures concerning other regions of the bodysuch as the prostate, liver, brain, gall bladder, uterus and other solidorgans.

I. Internal Indifferent Electrode Device

As shown by way of example in FIGS. 1-3, an internal indifferentelectrode device 10 in accordance with a preferred embodiment of apresent invention includes a shaft 12 that supports a plurality ofelectrodes 14. The electrodes 14 form part of a return path for tissuecoagulation energy that is transmitted by another device in the mannerdiscussed in greater detail below in Section IV below. Additionalinformation concerning the type, size, structure and spacing of theelectrodes 14, as well as other electrodes that may be employed ininternal indifferent electrode devices, is provided in Section IIIbelow.

The shaft 12 should be between about 18 inches and about 24 inches inlength, with an outer diameter between about 2 mm and about 4 mm. Theexemplary embodiment, which is intended for use in cardiovascularapplications, is about 18 inches in length with an outer diameter ofabout 3 mm. The shaft 12 should also be very flexible. Flexiblebiocompatible thermoplastic tubing such as unbraided Pebax® material,polyethylene, or polyurethane tubing may be used to form the shaft 12.The proximal end of the shaft 12 is connected to a base 16 by a cable18. The base 16 is preferably formed from molded plastic. The cable 18,which is preferably formed from polyurethane tubing because thismaterial is flexible and durable, will typically be about 10 feet long.An end cap (not shown) is secured within the distal end of the shaft 12.

The exemplary internal indifferent electrode device 10 is adapted to beused in conjunction with an automatic personality module (APM), such asthe Model 882 sold by EP Technologies Inc. of San Jose, Calif., or anelectrosurgical unit (ESU) such as the Model 4810 which is also sold byEP Technologies, Inc. and is generally represented by reference numeral20 in FIG. 4. The exemplary ESU 20, which is used to supply and controlpower to a surgical probe or other electrophysiological device, includesa plurality of displays 22, as well as buttons 24, 26 and 28 that arerespectively used to control which of the electrodes on theelectrophysiological device receive power, the level of power suppliedto the electrodes, and the temperature at the electrodes.

Power is supplied to the surgical probe or other electrophysiologicaldevice by way of a power output connector 30. Lesion creation proceduressometimes require that up to 2 amperes be returned to the ESU 20 and, tothat end, two indifferent patch electrodes that can handle up to 1ampere apiece are attached to the patient's skin and individuallyconnected to the APM or ESU in conventional procedures. The indifferentpatch electrodes are connected to a pair of power return connectors 32and 34 on the ESU 20.

The exemplary internal indifferent electrode device 10 illustrated inFIGS. 1-3 is provided with eight spaced electrodes 14 that together actlike a large single indifferent return electrode, thereby obviating theneed for the conventional external patch electrodes described above.Each of the electrodes is connected to a respective wire 36 that runsthrough the shaft 12 and the cable 18 into the base 16. There, the wiresare separated. Four of the wires 36 are connected to a connector 38 andthe other four wires are connected to a connector 40. The power returnconnectors 32 and 34 in the exemplary ESU 20 illustrated in FIG. 4 eachhave a rectangular profile and recessed male pins 36, while the poweroutput connector 30 has a circular profile. In order to mate with therectangular power return connectors 32 and 34, the connectors 38 and 40on the exemplary internal indifferent electrode device include a matingportion 42 with a rectangular profile and longitudinally extendingfemale pin-connects 44. The profile need not be perfectly rectangular solong as the profile substantially corresponds to that of the powerreturn connectors 32 and 34. For example, the middle of the top andbottom surfaces of mating portion 42 may include longitudinallyextending grooves for mechanical keying with the correspondingconnector.

Internal indifferent electrode devices in accordance with the presentinvention are not required to be configured in the manner describedabove. Instead, their configuration will depend upon the overall systemswith which they are used and the requirements thereof. If, for example,an APM or ESU only included a single power return connector, then all ofthe wires 20 from the electrodes 14 would be connected to a singleconnector on the internal indifferent electrode device. Additionally,the shape and style of the power return connectors 32 and 34 and thecorresponding mating portions 42 on the connectors 38 and 40 need not berectangular. However, in preferred embodiments, both should have thesame general shape and this shape should be different than the shape ofthe power output connector 30, which need not be circular, to preventusers from attempting to plug an indifferent electrode device into apower output connector and/or an electrophysiological device into apower return connector. Alternatively, the power output power returnconnectors could have the same general shape and noticeably differentsizes to prevent confusion. Color coding may also be used.

A two-part base member including a re-usable proximal portion thatsupports the connectors 38 and 40, a disposable distal portion thatsupports the cable 18 and shaft 12, and a pair of mating PC cards thatconnect the two portions may also be used.

II. Electrophysiological Procedure Kit

As illustrated for example in FIG. 5, the internal indifferent electrodedevice 10 may form one portion of an electrophysiological procedure kit46 that also includes a surgical probe 48 or some other device that iscapable of transmitting energy through tissue to the internalindifferent electrode. Two examples of suitable surgical probes are theCobra® surgical probe and the ThermaLine™ surgical probe, bothmanufactured by EP Technologies, Inc. in San Jose, Calif. Additionalexamples of surgical probes that may form a portion of theelectrophysiological procedure kit 46 are provided in U.S. Pat. No.6,142,994. The other tools and devices required for a particularprocedure may be provided within the kit itself or simply providedseparately.

The internal indifferent electrode device 10 and surgical probe 48 arehoused in a sterile package 50 that has a flat rigid bottom portion 52and a top transparent top cover 54 that provides recesses for theinternal indifferent electrode device, surgical probe and any otherincluded tools, thereby providing a ready to use surgical kit. Thebottom portion 52 may be formed from Tyvek® spun bonded plastic fibers,or other suitable materials, which allow the contents of the package tobe sterilized after the tools are sealed within the package.

Turning to FIGS. 6-10, the exemplary surgical probe 48 includes arelatively short shaft 50, a handle 52 and a distal section 54. Theshaft 50 preferably consists of a hypotube 56, which is either rigid orrelatively stiff, and an outer polymer tubing 58 over the hypotube. Theshaft 50 in the illustrated embodiment may be from 4 inches to 18 inchesin length, and is preferably 6 to 8 inches, while the distal section 54may be from 1 inch to 10 inches in length, and is preferably 2 to 3inches. The handle 52 preferably consists of two molded handle halvesand is provided with strain relief element 60. A plurality of electrodes62 or other energy transmission devices are provided on the distalsection 54. There are seven electrodes 62 in the illustrated embodiment.Additional details concerning the electrodes 62 are provided in SectionIII below. A tissue cooling apparatus 64 is positioned over theelectrodes 62 in the exemplary embodiment to cool tissue during lesionformation procedures.

The distal section 54 is preferably either entirely malleable, entirelysomewhat flexible, or includes a malleable proximal portion and asomewhat flexible distal portion. A flexible version of the distalsection 54 preferably includes a flexible spring member 66 that issecured to the hypotube 56 and enclosed in a flexible body 68 formedfrom Pebax® material, polyurethane, or other suitable materials. [FIG.9.] The distal end of the spring member 66 is secured to a tip member70. An insulating sleeve 72 is placed over the spring member 66. Thespring member 66 may be replaced by a malleable mandrel 74 that issecured to the hypotube 56 and tip member 70, as illustrated for examplein FIG. 10. An insulating sleeve 76 is placed over the malleable mandrel74. Another alternative arrangement is to have a distal section 54 thathas a malleable proximal portion and a flexible distal portion composedof a short malleable mandrel and a short spring member that are securedto one another with a crimp tube. The short malleable mandrel would alsobe secured to the hypotube 56, while the short spring member would besecured to the tip member 70.

As used herein the phrase “relatively stiff’ means that the shaft (ordistal section or other structural element) is either rigid, malleable,or somewhat flexible. A rigid shaft cannot be bent. A malleable shaft isa shaft that can be readily bent by the physician to a desired shape,without springing back when released, so that it will remain in thatshape during the surgical procedure. Thus, the stiffness of a malleableshaft must be low enough to allow the shaft to be bent, but high enoughto resist bending when the forces associated with a surgical procedureare applied to the shaft. A somewhat flexible shaft will bend and springback when released. However, the force required to bend the shaft mustbe substantial. Rigid and somewhat flexible elements are preferablyformed from stainless steel, while malleable elements may be formed fromannealed stainless steel or beryllium copper. With respect to the springmember, Nitinol as well as 17-7 and carpenter's steel are preferred.Additional information concerning the formation of, and materials for,the relatively short shaft 38 and the distal section 54 is provided inU.S. Pat. No. 6,142,994.

The exemplary tissue cooling apparatus 64 illustrated in FIGS. 6 and 7employs conductive fluid to cool tissue during coagulation procedures.More specifically, heat from the tissue being coagulated is transferredto ionic fluid to cool the tissue while energy is transferred from theelectrodes or other energy transmission device(s) to the tissue throughthe fluid by way of ionic transport. The conductive fluid is pumpedthrough the tissue cooling apparatus 64, and preferably continuously, tocool tissue and facilitate the formation of lesions that are wider anddeeper than those that could be realized with an otherwise identicaldevice which lacks the cooling apparatus.

The exemplary tissue cooling apparatus 64 includes a microporous outercasing 78 mounted on the probe distal section 54 over the electrodes 62.The proximal and distal ends of the outer casing 78 are secured withanchoring devices 80 and 82 that are preferably formed from heat shrinktubing. A fluid transmission space 84 between the inner surface of theouter casing 78 and the outer surface of the distal section 54 andelectrodes 62 extends uninterrupted from a fluid supply line 86 to afluid drainage tube 88. [Note arrows F.] The ends of the supply line 86and drainage tube 88 that terminate within the outer casing 78 aresecured with anchoring devices 80 and 82. The fluid supply line 86 isalso secured to the exterior of shaft 50 with an anchoring device 90.

The microporous outer casing 78 should be no larger than 3 times thediameter of the electrodes 62 and will preferably be 1.2 to 2 times theelectrode diameter. This translates to a fluid transmission space 84that is typically about 0.005 to 0.020 inch, measured inner surface toouter surface, but can be as large as 0.1 inch. Of course, other sizesmay be used if they are required by a particular application.

The ionic fluid, which is supplied under pressure from a fluid source(not shown) to fluid supply line 86, heats up as it passes through thetransmission space 84. The drainage tube 88 directs heated ionic fluidinto a receptacle outside the patient. Removal of the heated ionic fluidis important because it will be hot enough (typically about 60° C. whenit reaches the distal end of the probe) to burn the patient if allowedto drip into the thorax.

The electrically conductive ionic fluid preferably possesses a lowresistivity to decrease ohmic loses, and thus ohmic heating effects,within the microporous outer casing 78. The composition of theelectrically conductive fluid can vary. In the illustrated embodiment,the fluid is a hypertonic saline solution, having a sodium chlorideconcentration at or near saturation, which is about 5% to about 25%weight by volume. Hypertonic saline solution has a relatively lowresistivity of only about 5 ohm-cm, as compared to blood resistivity ofabout 150 ohm-cm and myocardial tissue resistivity of about 500 ohm-cm.Alternatively, the ionic fluid can be a hypertonic potassium chloridesolution.

With respect to temperature and flow rate, a suitable inlet temperaturefor epicardial applications (the temperature will, of course, rise asheat is transferred to the fluid) is about 0 to 25° C. with a constantflow rate of about 2 to 20 ml/min. The flow rate required forendocardial applications where blood is present would be aboutthree-fold higher (i.e. 6 to 60 ml/min.). Should applications sorequire, a flow rate of up to 100 ml/min. may be employed. In a closedsystem where the fluid is stored in a flexible bag, such as the Viaflex®bag manufactured by Baxter Corporation, and heated fluid is returned tothe bag, it has been found that a volume of fluid between about 200 and500 ml within the bag will remain at room temperature (about 22° C.)when the flow rate is between about 2 ml/min. and 20 ml/min.Alternatively, in an open system, the flexible bag should include enoughfluid to complete the procedure. 160 ml would, for example, be requiredfor a 20 minute procedure where the flow rate was 8 ml/min.

The fluid pressure within the microporous outer casing 78 should beabout 30 mm Hg in order to provide a structure that will resilientlyconform to the tissue surface in response to a relatively small forcenormal to the tissue. Pressures above about 100 mm Hg will cause theouter casing 78 to become too stiff to properly conform to the tissuesurface. For that reason, the flow resistance to and from the outercasing 78 should be relatively low.

The pores in the microporous outer casing 78 allow the transport of ionscontained in the fluid through the casing and into contact with tissue.Thus, when the electrodes 62 transmit RF energy into the ionic fluid,the ionic fluid establishes an electrically conductive path through theouter casing 78 to the tissue being coagulated. Regenerated cellulosemembrane materials, typically used for blood oxygenation, dialysis, orultrafiltration, are a suitable microporous material for the outercasing 78. The thickness of the material should be about 0.002 to 0.005inch. Although regenerated cellulose is electrically non-conductive, therelatively small pores of this material allow effective ionic transportin response to the applied RF field. At the same time, the relativelysmall pores prevent transfer of macromolecules through the material, sothat pressure driven liquid perfusion is less likely to accompany theionic transport, unless relatively high pressure conditions developwithin the outer casing 78.

Hydro-Fluoro™ material, which is disclosed in U.S. application Ser. No.09/573,071, filed May 16, 2000, and incorporated herein by reference, isanother material that may be used. Materials such as nylons (with asoftening temperature above 100° C.), PTFE, PEI and PEEK that havemicropores created through the use of lasers, electrostatic discharge,ion beam bombardment or other processes may also be used. Such materialswould preferably include a hydrophilic coating. Microporous materialsmay also be fabricated by weaving a material (such as nylon, polyester,polyethylene, polypropylene, fluorocarbon, fine diameter stainlesssteel, or other fiber) into a mesh having the desired pore size andporosity. These materials permit effective passage of ions in responseto the applied RF field. However, as many of these materials possesslarger pore diameters, pressure driven liquid perfusion, and theattendant transport of macromolecules through the pores, are also morelikely to occur. Considerations of overall porosity (discussed below)and perfusion rates must be taken more into account as pore sizeincreases.

The electrical resistivity of the outer casing 78 will have asignificant influence on lesion geometry and controllability.Low-resistivity (below about 500 ohm-cm) requires more RF power andresults in deeper lesions, while high-resistivity (at or above about 500ohm-cm) generates more uniform heating and improves controllability.Because of the additional heat generated by the increased bodyresistivity, less RF power is required to reach similar tissuetemperatures after the same interval of time. Consequently, lesionsgenerated with high-resistivity structures usually have smaller depth.The electrical resistivity of the outer casing can be controlled byspecifying the pore size of the material, the porosity of the material,and the water adsorption characteristics (hydrophilic versushydrophobic) of the material. A detailed discussion of thesecharacteristics is found in U.S. Pat. No. 5,961,513, which is entitled“Tissue heating and Ablation Systems and Methods Using Porous ElectrodeStructures” and is incorporated herein by reference. A suitableelectrical resistivity for epicardial and endocardial lesion formationis about 1 to 3000 ohm-cm measured wet.

Generally speaking, low or essentially no liquid perfusion through themicroporous outer casing 78 is preferred. When undisturbed by attendantliquid perfusion, ionic transport creates a continuous virtual electrodeat the electrode body-tissue interface. The virtual electrodeefficiently transfers RF energy without need for an electricallyconductive metal surface.

Pore diameters smaller than about 0.1 μm retain macromolecules, butallow ionic transfer through the pores in response to the applied RFfield. With smaller pore diameters, pressure driven liquid perfusionthrough the pores is less likely to accompany the ionic transport,unless relatively high pressure conditions develop within the outercasing 78. Larger pore diameters (up to 8 μm) can also be used to permitionic current flow across the membrane in response to the applied RFfield. With larger pore diameters, pressure driven fluid transportacross the membrane is much higher and macromolecules (such as protein)and even small blood cells (such as platelets) could cross the membraneand contaminate the inside of the probe. Red blood cells would normallynot cross the membrane barrier, even if fluid perfusion across themembrane stops. On balance, a pore diameter of 1 to 5 μm is suitable forepicardial and endocardial lesion formation. Where a larger porediameter is employed, thereby resulting in significant fluid transferthrough the porous region, a saline solution having a sodium chlorideconcentration of about 0.9% weight by volume would be preferred.

With respect to porosity, which represents the volumetric percentage ofthe outer casing 78 that is composed of pores and not occupied by thecasing material, the magnitude of the porosity affects electricalresistance. Low-porosity materials have high electrical resistivity,whereas high-porosity materials have low electrical resistivity. Theporosity of the outer casing 78 should be at least 1% for epicardial andendocardial applications employing a 1 to 5 μm pore diameter.

Turning to water absorption characteristics, hydrophilic materials aregenerally preferable because they possess a greater capacity to provideionic transfer of RF energy without significant liquid flow through thematerial.

Certain other considerations are applicable to those embodiments whichare endocardial in nature and, therefore, operate within the blood pool.Most notably, there should be essentially no liquid perfusion. Thislimits salt or water overloading caused by transport of the hypertonicsolution into the blood pool. This is especially true when thehypertonic solution includes potassium chloride. Additionally, the ionictransport rate should below about 10 mEq/min when the hypertonicsolution includes potassium chloride.

Nonporous outer casings (not shown) that are both electrically andthermally conductive may be used in place of the porous outer casing 78.A nonporous outer casing may, for example, have the same configurationas the porous outer casing 78. As with the porous outer casing, theresistivity across the nonporous outer casing should be about 1 ohm-cmto about 3000 ohm-cm measured wet. The nonporous outer casing shouldalso enable a transfer of 10 W of power with a 10° C. temperaturegradient across the nonporous outer casing for each cm of length, asshould the porous outer casing 78. For example, at least 80 W of thermalenergy should transfer across a 4 cm length of outer casing if thereexists a 20° C. temperature difference between the inner and outercasing surfaces. Suitable materials for the conductive nonporous outercasing include plastic materials (such as polyurethane) which are highlyloaded with metallic additives or carbon fibers. Elastomers (such assilicone rubber) can also be loaded with conductive additives to achievethermal and electrical conductivities in the ranges required for thisapplication.

Other methods of cooling tissue may also be employed where appropriate.Suitable methods include Joule-Thompson cooling, Peltier diode cooling(cooling using semiconductor devices that generate heat on one sidewhile heat is removed on the other) and, in the context of wettablefluid retention elements, active vaporization.

As illustrated for example in FIG. 11, the exemplary surgical probe 48may be provided with a connection device 92 that connects the surgicalprobe to the ESU 20. The connection device 92 includes a connector 94that may be inserted into an opening 96 in surgical probe handle 52(FIG. 6), a cable 98, and a connector 100 that has a shape and sizecorresponding to that of the power output connector 30 on the ESU 20(FIG. 4).

Additional details concerning the surgical probe 48 and other similardevices is provided in U.S. patent application Ser. No. 09/761,981,which is entitled “Fluid Cooled Apparatus For Supporting Diagnostic AndTherapeutic Elements In Contact With Tissue” and incorporated herein byreference.

III. Electrodes, Temperature Sensing And Power Control

The electrodes 14 and 62 are preferably in the form of wound, spiralclosed coils. The coils are made of electrically conducting material,like copper alloy, platinum, or stainless steel, or compositions such asdrawn-filled tubing (e.g. a copper core with a platinum jacket). Theelectrically conducting material of the coils can be further coated withplatinum-iridium or gold to improve its conduction properties andbiocompatibility. A preferred design is disclosed in U.S. Pat. No.5,797,905.

Alternatively, the electrodes 14 and 62 may be in the form of solidrings of conductive material, like platinum, or can comprise aconductive material, like platinum-iridium or gold, coated upon thedevice using conventional coating techniques or an ion beam assisteddeposition (IBAD) process. For better adherence, an undercoating ofnickel, silver or titanium can be applied. The electrodes can also be inthe form of helical ribbons. The electrodes can also be formed with aconductive ink compound that is pad printed onto a non-conductivetubular body. A preferred conductive ink compound is a silver-basedflexible adhesive conductive ink (polyurethane binder), however othermetal-based adhesive conductive inks such as platinum-based, gold-based,copper-based, etc., may also be used to form electrodes. Such inks aremore flexible than epoxy-based inks Open coil electrodes may also beemployed. Referring more specifically to the electrodes 62 on thesurgical probe 48, given that the purpose of the electrodes 62 is totransfer energy into the ionic fluid, as opposed to directly intotissue, the electrodes 62 may even be replaced by a straight piece ofbare wire.

The exemplary electrodes 14 on the internal indifferent electrode device10 are preferably 12.5 mm long coil electrodes with 3 mm spacing. Thisarrangement will prevent any one of the electrodes 14 from functioningas a lesion forming device because the large overall surface area of theelectrodes ensures that the current density is low enough to preventsignificant heating. Nevertheless, the electrodes 14 may range fromabout 4 mm to about 100 mm in length and the exemplary plurality ofspaced electrodes may be replaced by a relatively long single coilelectrode or other energy transmission device.

The exemplary electrodes 62 are preferably coil electrodes that areabout 4 mm to about 20 mm in length. In the preferred embodiments, theelectrodes 62 are 12.5 mm in length with 1 mm to 3 mm spacing, whichwill result in the creation of continuous lesion patterns in tissue whencoagulation energy is applied simultaneously to adjacent electrodes. Forrigid electrodes, the length of the each electrode can vary from about 2mm to about 10 mm. Using multiple rigid electrodes longer than about 10mm each adversely effects the overall flexibility of the device, whileelectrodes having lengths of less than about 2 mm do not consistentlyform the desired continuous lesion patterns.

Referring to FIGS. 6-10, RF power (or other power) from an ESU 20 orother power supply and control device is supplied to the electrodes 62by conducting wires 102. The conducting wires 102 are connected to a PCboard 104, which is located within the handle 52 and adapted to matewith the connector 94. A plurality of temperature sensors 106, such asthermocouples or thermistors, may be located on, under, abutting thelongitudinal end edges of, or in between, the electrodes 62.Alternatively, a sensor could simple be located at or near the locationwhere the fluid exits the tissue cooling apparatus 64 in order todetermine the temperature of the fluid at its hottest point. Signalsfrom the temperature sensors are transmitted to the power supply andcontrol device by way of wires 108 that are also connected to the PCboard 104. A reference thermocouple may also be provided if desired.Suitable temperature sensors and power supply and control devices aredisclosed in U.S. Pat. Nos. 5,456,682, 5,582,609 and 5,755,715.

The amount of power required to coagulate tissue ranges from 5 to 150 wand depends on parameters such as set temperature and the flow rate ofthe ionic fluid. For epicardial lesion formation using the coolingapparatus 64 illustrated FIGS. 6 and 7 with a 6 mm diameter, it has beenfound that an 80° C. electrode temperature can be maintained with a 8ml/min. ionic fluid flow rate when 75 w of power is supplied to eachelectrode for about 60 seconds. It has been found that these parametersproduce lesions, both epicardial and endocardial that are at least 20 mmwide and 18 mm deep.

High voltage gradients have also been used to create lesions bydielectrically breaking down cell membranes to kill tissue. Voltagegradients above 500V/cm created by short bursts of RF current arepreferred. In the context of the present inventions, placing theexemplary internal indifferent electrode device 10 inside a heartchamber (such as the left atrium) and the surgical probe electrodes 62on the epicardial surface would increase the voltage gradient across theheart wall as compared to situations where a conventional patchelectrode is placed on the patient's skin. Such an arrangement alsolimits peripheral tissue damage. Additional information concerning theuse of high voltage gradients to create lesions is provided in U.S. Pat.No. 6,107,699.

IV. Methods

The formation of epicardial lesions is one example of a procedure thatmay be performed in accordance with the present inventions. Asillustrated for example in FIG. 12, an internal indifferent electrodedevice, such as the exemplary internal indifferent electrode device 10,may be placed within the blood pool in the left atrium during anepicardial lesion formation procedure in which an energy transmittingdevice, such as the energy transmitting portion of the surgical probe48, is placed on the epicardial surface. The internal indifferentelectrode device may, alternatively, be placed within other open spaceswithin the heart such as the superior vena cava, the inferior vena cavaor the other chambers depending on the location of the energytransmitting device.

Access to the heart may be obtained via a thoracotomy, thoracostomy ormedian sternotomy. Ports may also be provided for cameras and otherinstruments. The internal indifferent electrode device 10 may beinserted into the atrium through an atrial appendage and a purse stringtechnique may be used to secure it in place and prevent the flow ofblood through the appendage. Alternatively, the internal indifferentelectrode device 10 may be inserted into the atrium by way of thejugular vein using a Seldinger technique.

Tissue coagulating energy from the surgical probe electrodes 62 will betransmitted across the atrial wall and through the blood in the leftatrium to the electrodes 14 on the internal indifferent electrode device10 to form the transmural lesion in the atrial wall. Additional lesionsmay be formed by moving the energy transmitting portion of the surgicalprobe 48 to other places on the epicardial surface and transmittingenergy through tissue to the internal indifferent electrode device 10.The internal indifferent electrode device 10 may also be moved asnecessary.

There are a number of advantages associated with placing an internalindifferent electrode device within the blood pool in the heart, asopposed to the patient's skin. For example, the resistivity of blood isrelatively low (about 150 ohm-cm) as compared to other body tissues,while the internal indifferent electrode device adds less impedance thando external patch electrodes. Thus, the effectiveness of the lesionformation process will be improved because the lowest impedance pathfrom the surgical probe electrodes 62 to the return electrodes 14 on theinternal indifferent electrode device 10 is directly across the atrialwall and through the blood. The flowing blood will also cool theelectrodes 14, thereby reducing the likelihood of local tissue burningthat is sometimes associated with external patch electrodes.Additionally, poor tissue contact, which can create problems whenexternal patch electrodes are employed, is not an issue when an internalindifferent electrode device is placed into the blood pool.

The present lesion formation methods in accordance with the presentinventions may also be practiced with catheters. For example, instead ofsurgically inserting the exemplary internal indifferent electrode 10into heart, a catheter including one or more indifferent electrodes maybe percutaneously advanced into the left atrium or another region orchamber within the heart. Once the indifferent electrode(s) on thecatheter are in the blood pool, tissue coagulating energy may bedelivered to the epicardial surface by, for example, the electrodes onthe surgical probe 48 to form a transmural lesion in the mannerdescribed above. Alternatively, instead of employing a surgical probe, acatheter carrying one or more energy emitting electrodes may bepercutaneously directed to a different region or chamber than thecatheter that is carrying the indifferent electrodes. The energyemitting electrodes on the catheter may then be used to transmit energyacross an internal wall within the heart to the indifferent electrodeson the other catheter to create a transmural lesion.

Regardless of the type of device supporting the indifferent electrodesin the above-described lesion formation methods, the indifferentelectrodes will normally be slightly spaced from the endocardialsurface. Nevertheless, should it be desired that the indifferentelectrodes also function as coagulation electrodes to further increasethe likelihood of a transmural lesion, they may be positioned againstthe endocardial surface in close proximity to the electrodes on theepicardial surface (or other side of an internal wall) that aretransmitting the energy.

Although the present inventions have been described in terms of thepreferred embodiments above, numerous modifications and/or additions tothe above-described preferred embodiments would be readily apparent toone skilled in the art. For example, the scope of the inventionsincludes any combination of the elements from the various species andembodiments disclosed in the specification that are not alreadydescribed. It is intended that the scope of the present inventionsextend to all such modifications and/or additions and that the scope ofthe present inventions is limited solely by the claims set forth below.

1. A kit for transmitting energy through a tissue structure within abody of a patient, the tissue structure having a wall defining a firstside and a second side, the kit for use with a power supply apparatusincluding a power output and a power return, the kit comprising: aninternal indifferent electrode device including an elongated shaftincluding a distal portion including one or more electrodes configuredfor positioning within the body of the patient on one of the first sideand the second side of the tissue structure wall, and a proximal portionadapted to be connected to the power return of the power supplyapparatus; and an electrophysiological device including a distal portionincluding one or more electrodes configured for positioning within thebody on the other of the first side and the second side of the tissuestructure wall, and a proximal portion adapted to be connected to thepower output of the power supply apparatus.
 2. The kit of claim 1,further comprising a tissue cooling member positioned over the one ormore electrodes of the electrophysiological device.
 3. The kit of claim2, wherein the tissue cooling member includes a sleeve disposed over theone or more electrodes, the sleeve defining a fluid transmission spacebetween an outer surface of the electrodes and an inner surface of thesleeve.
 4. The kit of claim 3, wherein the tissue cooling memberincludes a fluid drain tube extending from a distal end of theelectrophysiological device and configured to drain cooling fluid fromthe fluid transmission space to outside the body.
 5. The kit of claim 3,wherein the sleeve is microporous.
 6. The kit of claim 5, wherein themicroporous sleeve has a pore diameter of 1 to 5 μm.
 7. The kit of claim5, wherein the microporous sleeve has a pore diameter of less than 0.1μm.
 8. The kit of claim 3, wherein the sleeve is non-porous.
 9. The kitof claim 3, wherein the sleeve is made of a hydrophilic material. 10.The kit of claim 4, wherein the fluid drain tube is connected to a fluidsupply source, defining a closed fluid supply system.
 11. The kit ofclaim 4, wherein the fluid drain tube is connected to a receptacle thatis separate from a fluid supply source, thereby defining an open fluidsupply system.
 12. A method of transmitting energy through a tissuestructure in a body having a wall defining a first side and a secondside, the method comprising the steps of: positioning an internalindifferent electrode device within the body on the first side of thetissue structure wall; positioning an electrophysiological deviceincluding a tissue cooling apparatus within the body on the second sideof the tissue structure wall; transmitting energy from theelectrophysiological device to the internal indifferent electrodedevice; and cooling the tissue structure while transmitting energy,wherein cooling the tissue structure includes flowing fluid through thetissue cooling apparatus.
 13. The method of claim 12, further comprisingflowing the fluid from a fluid supply source through the tissue coolingapparatus and draining the fluid into a receptacle outside the body. 14.The method of claim 13, wherein the electrophysiological device includesone or more electrodes and the tissue cooling apparatus includes asleeve positioned over the one or more electrodes, the sleeve defining afluid transmission space between an outer surface of the electrodes andan inner surface of the sleeve.
 15. The method of claim 14, wherein thetissue cooling apparatus includes a fluid drain tube extending from adistal end of the electrophysiological device outside of the body,wherein flowing fluid through the tissue cooling apparatus includesflowing fluid from a fluid supply source, through the fluid transmissionspace in the sleeve, and draining the fluid from the drain tube to areceptacle outside the body.
 16. The method of claim 15, wherein thefluid supply source and the receptacle are in fluid communication,defining a closed fluid supply system.
 17. The method of claim 15,wherein the fluid supply source and the receptacle are separate,defining an open fluid supply system.
 18. The method of claim 12,wherein positioning an internal indifferent electrode device within thebody includes percutaneously advancing the indifferent electrode devicethrough a catheter and into a first heart chamber.
 19. The method ofclaim 18, wherein positioning an electrophysiological device includespercutaneously advancing the electrophysiological device through acatheter and into a second heart chamber.
 20. The method of claim 19,wherein the indifferent electrode device is positioned at a locationspaced apart from an endocardial surface.